EPA sacrifices science to protect fluoridation (PR)

Dear Readers,    

On Jan 7, 2011, the US Department of Health & Human Services (HHS) proposed lowering the recommended level used in the water fluoridation program to 0.7 ppm, because of the very high incidence of dental fluorosis among American children.  41% of ALL American children aged 12-15 are now impacted by this condition.

Simultaneous with this proposal, EPA's Office of Water (OW) released two documents: 

· the rationale for a proposed safe reference dose (RfD)
· an analysis of exposure to all sources of fluoride 

These two documents will be the basis for setting a new Maximum Contaminant Level Goal (MCLG) for fluoride in drinking water.  The MCLG is not an enforceable standard but rather an ideal goal derived from the lowest dose found to cause harm coupled with an appropriate margin of safety to protect everyone.

Based on the MCLG, the EPA's OW will then determine the enforceable standard, the Maximum Contaminant Level (MCL), which takes costs into consideration. Because there are many communities across the US that have high levels of naturally occurring fluoride in their water (1 to 4 over ppm), and because the cost to remove the fluoride is very expensive, these costs will be the major factor in determining the new standard for the level of fluoride in U.S. drinking water.

A major concern at this moment is to make sure that EPA's OW uses the best science and chooses an appropriate margin of safety to determine a SAFE RfD and thence a SAFE MCLG. Unfortunately, the EPA has not done this. Instead, EPA's Office of Water (OW) obliterated the science basis of the RfD (and thence the all-important MCLG) when in a joint media release with HHS on January 7, 2011, Peter Silva, EPA Assistant Administrator for the OW, stated:

"EPA's new analysis will help us make sure that people benefit from tooth decay prevention while at the same time avoiding the unwanted health effects from too much fluoride" (our emphasis), (HHS, 2011).  

 This is a clear indication that the OW is planning to work backwards from an RfD  pre-determined to protect the water fluoridation program and not the health of the American people. It is highly likely in our view that levels of fluoride lower than used in the water fluoridation program cause harm. But whether that is the case or not it is absolutely essential that the EPA use the best science with appropriate safety margins to determine an MCLG that will protect everyone's drinking water in the U.S. This process should not be corrupted beforehand by a determination to protect children's teeth from a very small - if any - amount of tooth decay. And the proposed lowered level of 0.7ppm fluoride in will not end dental fluorosis, albeit that is the rationale behind the lowering. There are other tissues in the body besides teeth (such as the brain, bone, kidney, etc.) and the EPA is obliged in setting an MCLG to protect all of these.

The public was given 90 days to submit comments on OW's RfD and Exposure documents and the deadline for comments was April 19, 2011.

Before we discuss our April 19 submissions here is a little more background information. Eight years ago the OW asked the National Academies to review its water standards for fluoride. This resulted in the publication of a review by the National Research Council Fluoride in Drinking Water: A scientific review of EPA's drinking water standards on March 22, 2006. The panel concluded that the current MCLG, currently set at 4 ppm, was not protective of health and recommended that the EPA perform a risk assessment to determine a new MCLG. Independent observers (e.g. Carton, 2006), argued that if the EPA were to do an honest job on this (applying routine safety factors as used for other pollutants) a new MCLG would have to be set at zero, bringing the fluoride MCLG into line with the MCLGs for both arsenic and lead. Such a finding would scuttle the water fluoridation program (where fluoride is added to water in the range 0.7 to 1.2 ppm).

It has taken the EPA nearly 5 years to respond to the NRC recommendations. Sadly, as indicated above, the EPA has decided not to do their job honestly. Presumably bowing to pressures from the HHS (i.e. the Oral Health Division of the CDC), the OW has decided to protect the water fluoridation program rather than protect the health of the American people.

On April 19, a team from FAN led by Tara Blank, PhD (FAN's science and health officer) provided two submissions to the EPA Office of Water (OW):

I) Comments on the U.S. EPA’s Report Fluoride: Dose-Response Analysis for Non-Cancer Effects  

II) Comments on the U.S. EPA’s Report Fluoride: Exposure and Relative Source Contribution Analysis  

Also on our website you will find submissions from

Kathleen Thiessen PhD, one of the NRC panel members and also from Bill Osmunson DDS, MPH 

We would like to congratulate particularly Tara and Ellen for this massive effort (they had some help from myself, Michael Connett and Chris Neurath). Note particularly the table that appears in Appendix A to both reports. This table  (pdf) -or htmlversion-  presents a selected and annotated list of the many peer-reviewed scientific studies on various aspects of fluoride's toxicity that have been published since the NRC report (and ignored by the EPA).  

All these submissions show the many ways that the EPA's OW have manipulated and obfuscated the science to reach a pre-ordained position, namely an RfD (safe reference dose) designed to allow the continuation of the water fluoridation program regardless of the harm it is causing. FAN's bottom line is simple: the OW can't protect both the water fluoridation program and produce a SAFE reference dose (and thence a safe MCLG). The OW had to choose between these two contradictory goals and it has chosen badly.

Below we have put excerpts from our conclusions to the Reference Dose submission.

Meanwhile, for those who would like to see scientific integrity re-established we are preparing a petition to be sent to Congress appealing for them to insist that the EPA determine an MCLG honestly, without making the process subservient to the needs of the dental lobby at the CDC.

Paul Connett, Director,

Fluoride Action Network

http://fluoridealert.org/ 

FAN's conclusions:

It is very clear that the EPA's Office of Water (OW) is not meeting the letter of the law in the Safe Drinking Water Act to determine an MCLG (with the RfD being a key stepping stone) which protects everyone "from known and anticipated health effects." Nor is OW meeting the objective of achieving Environmental Justice that EPA director Lisa Jackson has put at the top of the EPA's agenda.

Not only has OW neglected to consider very important health effects of fluoride such as its ability to lower IQ, but even for the limited health effect it has considered - severe dental fluorosis - it has applied an uncertainty factor of 1, which means that no extra allowance has been made to protect minority children or children of low-income families. To make matters even worse, OW is indicating that in its development of a new MCLG it proposes to protect only 90% of the population; OW is ignoring the 10% of the population that consumes over two liters of water per day.

These glaring inadequacies have come about because the OW has taken on the impossible task of trying to determine a "safe" RfD while at the same trying to protect the water fluoridation program. Consideration of presumed benefits (which the OW did not even examine for itself) of a pollutant has no place in the scientific determination of a drinking water goal that is meant to be safe for everyone.  Had the EPA reviewed the literature on fluoridation's alleged benefits, it would have found the evidence very weak indeed.

There is only one course of action that is both legal and socially just in this matter. The OW must put aside any notion of protecting the fluoridation program, and develop an RfD (and thence an MCLG) that uses the best science and applies appropriate margins of safety to protect the whole U.S. population from all "known and anticipated" harmful effects of fluoride using appropriate margins of safety (or uncertainty factors). The OW documents made public on Jan 7, 2011 entirely fail to do that. The OW should not allow the protection of water fluoridation to distort this process. If water fluoridation is not safe then the EPA should tell the public so, and not play politics with the RfD determination to try to hide the facts...

Despite EPA claims to the contrary, fluoride is not a nutrient. It is not needed for any biochemical process.  However, it is very toxic for many biological processes.  In the early days of fluoridation it was known that fluoride could inhibit enzymes.  With time it has become clear that it can interfere with many other biological activities and defense mechanisms, as indicated in the following excerpt from a review article by Barbier et al. (2010):

"(T)his element interacts with cellular systems even at low doses. In recent years, several investigations demonstrated that ?uoride can induce oxidative stress and modulate intracellular redox homeostasis, lipid peroxidation and protein carbonyl content, as well as alter gene expression and cause apoptosis. Genes modulated by ?uoride include those related to the stress response, metabolic enzymes, the cell cycle, cell-cell communications and signal transduction."

With the knowledge that 41% of American children ages 12-15 now have some level of dental fluorosis (Beltrán-Aguilar et al., 2010), indicating that they have become over-exposed to fluoride, it is foolish to continue this practice a day longer.

Nature gave us the strongest clue that the newborn baby only needs a very, very small-if any-amount of fluoride, as the fluoride content of breast milk is maintained at a very low level (0.004 ppm; NRC, 2006).  To continue to expose babies and infants at over 200 times the level of fluoride present in mothers' milk is reckless in the extreme. While it may be difficult for long-term promoters of fluoridation to admit this reality, there is no reason-other than politics-for the EPA to countenance such recklessness.  It should return to its proper regulatory role of protecting the population against pollutants in the water, instead of continuing to promote the spurious benefit of delivering this medicine via the pubic water supply.

The Table of Contents for the Dose-Response document.

1.   Introduction

2.  Responses to EPA's Dose-Response Analysis

2.1.  The methodology and rationale behind OW's proposed RfD are flawed.

2.1.1.  Consideration of the adverse effects of fluoride should take precedence over any presumed benefits (of water fluoridation) in OW's determination of an RfD and MCLG that are safe for the entire population.

2.1.2.  OW has failed to offer convincing evidence that severe dental fluorosis should be considered the critical effect associated with exposure to fluoride.

2.1.3.  OW has failed to consider potential variation in responses to the different types of fluoride in drinking water.

2.2. OW has unnecessarily delayed consideration of the potential carcinogenicity of fluoride.

2.3. OW has failed to consider fluoride's effects on the brain.

2.4. OW has failed to consider fluoride as an endocrine disruptor.

2.5. OW has failed to consider the disproportionate impact on a number of susceptible populations in its analysis.

2.5.1.  OW has disregarded pregnant women and embryos/fetuses in its analysis.

2.5.2 . OW has completely ignored infants 0-6 months of age in its analysis, and has failed to consider the disproportionate burden placed on bottle-fed infants.

2.5.3.  OW has failed to consider the disproportionate impact on above-average water consumers, which account for at least 10% of the population.

2.5.4.  OW has failed to consider the disproportionate impact on minority Americans.

2.5.5.  OW has failed to consider the disproportionate burden placed on low-income families.

2.5.6.  OW has failed to consider the disproportionate harm to people with inadequate nutrition.

2.5.7.  OW has failed to consider those with impaired kidney function.

2.5.8.  OW has failed to consider those co-exposed to lead, arsenic, or aluminum.

2.5.9.  OW has failed to consider those with an increased sensitivity to fluoride.

3. Conclusions

4. References

Appendix A Selected studies published since the release of the National Research Council report,

Fluoride in Drinking Water: A Scientific Review of EPA's Standards, in March 2006.

II. The Table of Contents for the Exposure document.

1.  Introduction

2.  Response to EPA's Exposure and Relative Source Contribution Analysis

2.1.    The policies used to calculate fluoride exposures are flawed, especially when no margin of safety is applied.

2.1.1.   OW's policy of using the 90th percentile for water consumption ignores 10% of the U.S. population-nearly 31 million people.

2.1.2.   OW's policy of using the mean drinking water fluoride concentration ignores as much as half of the population whose drinking water has higher fluoride levels.

2.1.3.   OW's policy of using the average body weight of the population of interest ignores as much as half of the population in the lower 50th percentile for weight.

2.1.4.   OW has failed to consider studies of urinary fluoride excretion as an estimate of total fluoride intake.

2.2.  OW's has failed to consider fluoride exposures for several of the most sensitive groups-pregnant women, embryos/fetuses, and infants 0-6 months.

2.3.  OW has failed to adequately consider racial, ethnic, regional, and socioeconomic differences in food and beverage consumption patterns.

2.4.  OW has ignored several sources of fluoride as contributors to total intake.

 2.4.1.   OW has ignored fluoride exposures from several dental products, including professionally applied topical fluorides, mouthwashes, and various dental devices.

 2.4.2.   OW has failed to consider fluoride exposure from dietary fluoride supplements in its analysis.

 2.4.3.   OW has failed to consider pharmaceuticals and anesthetics that metabolize to the fluoride anion in its exposure analysis.

2.4.4.   OW has failed to consider ambient air as a source of fluoride in its exposure analysis.

2.4.5.   OW does not adequately consider exposure from cigarettes in its analysis.

3.  Conclusions

4. References

Appendix A Selected studies published since the release of the National Research Council report, Fluoride in Drinking Water: A Scientific Review of EPA's Standards, in March 2006.